In this podcast discussion, Generics Bulletin’s David Wallace talks to Informa Pharma Consulting’s Duncan Emerton about Celltrion’s CHMP nod for subcutaneous Remsima, the product’s imminent approval and launch, and what it means for the future of biosimilars.

UK concession prices have a history of often failing to keep up with rising prices in the marketplace. However, the latest figures from WaveData suggest that even when prices are falling, concessions can sometimes struggle to compensate independent pharmacists at an adequate price level.

Belgium’s competition regulator has announced that it is investigating practices that have restricted or prevented biosimilars from entering the market.

Acorda has been denied its request for the US Supreme Court to review a ruling that revolved around the ‘blocking-patent’ doctrine, which has led to invalidity rulings on patents protecting several major brands.

Pfenex’ PF708 version of Forteo, submitted under the US 505(b)(2) hybrid regulatory pathway, has been approved by the FDA. Marketing partner Alvogen is expected to launch as soon as the FDA decides on the product’s equivalence rating after Pfenex submits a key study.

The French government’s plans for more price cuts and new obligations on manufacturers to avert drug shortages will add another layer of complexity to an already complicated operating environment, says the industry.